Boston Scientific Corporation · Class II · Cleared Aug 14, 2023
| K-number | K232162 |
| Device name | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome |
| Applicant | Boston Scientific Corporation |
| Product code | KNS |
| Device class | Class II |
| Decision date | Aug 14, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 876.4300 |
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